MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310

{0}------------------------------------------------ K032484 Medtronic MiniMed Premarket Notification-510 (k) Medtronic MiniMed Countach Model MMT-310 Infusion set OCT 2 8 2003 ## SECTION C. 510(k) Summary In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, this 510(k) Summary is provided: Submitter: Medtronic MiniMed, 18000 Devonshire St., Northridge, CA 91325 Contact: Mirielle Mengotto (818) 576-4112 Name of Device: Medtronic MiniMed Paradigm Countach Infusion set Model MMT-310 Predicate Devices: Maersk Medical A/S Paradigm Silhouette Infusion sets Models MMT-377, 378, 379. 380 (Premarket notification K002138) Description of the Device: The Medtronic MiniMed Paradigm Countach infusion set Model MMT-310 is a disposable, single-use intended for use with Medtronic MiniMed external microinfusion pumps. The Paradigm Countach is an infusion set that uses a cannula with a disconnect. Intended Use of the Device: The Paradiam Countach infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products. Comparison of the Technological Features of the New Device and Predicate Device: The Paradigm Countach infusion set is substantially similar to the lawfully marketed predicate device. Both sets are intended for subcutaneous delivery of insulin from the infusion pump to the pump user and attaches proximally to a reservoir by means of a proprietary plastic connector, and insert distally into the device user's subcutaneous tissue with a removable stainless steel needle and a flexible catheter. Gerda Resch Manager, Regulatory Affairs Medtronic MiniMed 8/8/03 Date {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle. Public Health Service OCT 2 8 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Mirielle Mengotto Senor Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219 Re: K032484 Trade/Device Name: Medtronic MiniMed Paradigm Countach Infusion Set Model MMT-310 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: August 1, 2003 Received: August 12, 2003 Dear Ms. Mengotto: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Ms. Mengotto Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Clarks Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Ko32484 ## INDICATIONS FOR USE 510(k) Number: Device Name: Indications for Use: Medtronic MiniMed Paradigm Countach Infusion set Model MMT-310 The Paradigm Countach infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an infusion pump and reservoir. The set is not intended nor indicated for use with blood or blood products. Paver. Sheff for PXC (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) or Over-the-Counter Use